Fluoxetine for Visual Recovery After Ischemic Stroke "FLUORESCE"

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake inhibitor commonly used for depression, enhances visual recovery after an acute ischemic stroke.

Conditions

Interventions

  • Fluoxetine (ProzacĀ®)Drug
    Other Names: Patients receiving fluoxetine
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: 20 mg fluoxetine capsule by mouth once daily for 90 days
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Matching placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in size of visual field deficit (degrees) 6 months No
Secondary Improvement in size of visual field deficit (square degrees) 6 months No
Secondary Improvement in parametric mean deviation 6 months No
Secondary Functional field score 6 months No
Secondary Visual Function Questionnaire-25 score 6 months No
Secondary Patient Health Questionnaire-9 score 6 months No
Secondary Modified Rankin Scale score 90 days No
Secondary Post-stroke changes in cortical visual representation as measured by functional magnetic resonance imaging 6 months No
Secondary Post-stroke changes in retinal nerve fiber layer thickness 6 months No

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